Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-20 @ 1:13 AM
Study NCT ID:
NCT03677258
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2018-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elastisity Ultrasonic scanning of the scin - epidermis and dermis in 3 area of the face after injections of the Collagen and after injections of the Hyaluronic Acid', 'timeFrame': '3 months', 'description': 'To evaluate elasticity in Cheek, in forehead and glabella area scanned after each procedure and compare with screening results'}], 'secondaryOutcomes': [{'measure': 'Safety: to evaluate safety by comparing adverse events after injections of the Collagen and after injections of the Hyaluronic Acid', 'timeFrame': '3 months', 'description': 'To evaluate safety by comparing adverse events and their relationships with medical devices'}, {'measure': 'Microcirculation data after injections of the Collagen and after injections of the Hyaluronic Acid', 'timeFrame': '3 months', 'description': 'To evaluate results after each procedure and after 3 procedures by the laser Doppler fluorimetry'}, {'measure': '3D photo materials after injections of the Collagen and after injections of the Hyaluronic Acid', 'timeFrame': '3 months', 'description': 'To evaluete results of procedures by the Quantifirecare data'}, {'measure': 'GAIS scale data after injections of the Collagen and after injections of the Hyaluronic Acid', 'timeFrame': '3 months', 'description': 'To evaluete results of 1 procedures and after 3 procedures by the patient and by the doctor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Collagen', 'anti-age therapy', 'cosmetology', 'lifting'], 'conditions': ['Skin Aging']}, 'descriptionModule': {'briefSummary': 'This study evaluates the statistics of anti-age treatment in outpatient sites in Russia (involution indicators: clinical scales; instrumental diagnostics, ultrasonic scannings, assesment of allergic state, efficacy assesment in according with GAIS scale) in routine clinical practice with focus on collagen therapy.', 'detailedDescription': 'This non-interventional study covers 60 patients (females with involuntary changes of the face skin) from Russian sites.\n\nThe following data will be collected and analyzed after the end of treatment:\n\n* demography\n* assessment of allergic state\n* safety data\n* severity of aging effect\n* clinical scales results before 1visit and after end of treatment\n* GAIS effectiveness assessment\n* instrumental diagnostic before 1visit and after end of treatment\n* hydration\n* elasticity\n* microcirculation level\n* lipofuscin level\n* ultrasound scanning\n* derma echo density'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'Anti-aging therapy more popular for female patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed Inform Consent Form\n* only females\n* from 35 to 65 years old\n* 1-3 skin photo types\n* signs of age-related skin changes\n* absence of chronic disease in decompensation phase\n* refusal to receive any cosmetic procedures during the study\n\nExclusion Criteria:\n\n* pregnancy, lactation period\n* infection process, dermatoses, censers\n* systemic connective tissue diseases with skin and subcutaneous tissue damage\n* taking isotretinoin drugs for the previous 6 months\n* propensity to form hypertrophic and keloid scars\n* exacerbation or decompensation of chronic somatic diseases; infectious and oncological diseases\n* violations of blood coagulation, including iatrogenic (taking drugs that affect blood clotting)\n* taking antihistamines, glucocorticoids, NSAIDs, immunosuppressants and other drugs that affect the reactivity of the skin\n* hypersensitivity to the components of the studied medical device'}, 'identificationModule': {'nctId': 'NCT03677258', 'briefTitle': 'Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nearmedic Plus LLC'}, 'officialTitle': 'Non-interventional Study: Collagen Anti-age Treatment in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'COLLOST postmarketing study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen injections', 'description': '30 females with aging facial problems from 35 to 65 years old prescribed collagen ingection once every 3 weeks, cours of therapy - 3 procedures', 'interventionNames': ['Device: Collagen for injections 7%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid injections', 'description': '30 females with aging facial problems from 35 to 65 years old prescribed hyaluronic acid ingection once every 3 weeks, cours of therapy - 3 procedures', 'interventionNames': ['Device: Hyaluronic acid for injections 2%']}], 'interventions': [{'name': 'Collagen for injections 7%', 'type': 'DEVICE', 'otherNames': ['Collost'], 'description': 'Injection of medical device', 'armGroupLabels': ['Collagen injections']}, {'name': 'Hyaluronic acid for injections 2%', 'type': 'DEVICE', 'otherNames': ['Viscoderm'], 'description': 'Injection of medical device', 'armGroupLabels': ['Hyaluronic acid injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105066', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Institute of Plastic Surgery and Cosmetology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Anna Stenko, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Plastic Surgery and Cosmetology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nearmedic Plus LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institute of Plastic Surgery and Cosmetology, Moscow, Russia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}